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The 3DKnee™ System: A Post-Market Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00764673
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : March 2, 2011
Last Update Posted : March 2, 2011
Sponsor:
Information provided by:
Encore Medical, L.P.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Osteoarthritis
Rheumatoid Arthritis
Post Traumatic Arthritis
Varus Deformity
Avascular Necrosis
Intervention Device: 3DKnee
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Primary 3DKnee Implant
Hide Arm/Group Description Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Period Title: Overall Study
Started 71
Completed 59
Not Completed 12
Reason Not Completed
Death             1
Lost to Follow-up             3
Withdrawal by Subject             6
Revision of Device             2
Arm/Group Title Primary 3DKnee Implant
Hide Arm/Group Description Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Overall Number of Baseline Participants 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
  35.2%
>=65 years
46
  64.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants
69  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
49
  69.0%
Male
22
  31.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants
71
Operated Knee   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants
Right knee 36
Left knee 35
[1]
Measure Description: Affected knee which received the implant
Primary Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants
Osteoarthritis 69
Varus deformity 1
Post-traumatic arthritis 1
[1]
Measure Description: Physician diagnosis of indication for receiving a total knee implant.
1.Primary Outcome
Title Knee Society Score Evaluation
Hide Description The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).
Time Frame 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects who completed their 2 year visit.
Arm/Group Title Primary 3DKnee Implant
Hide Arm/Group Description:
Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: Average Knee Rating Score
82.9  (25.7)
2.Primary Outcome
Title Knee Society Function Score
Hide Description The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.
Time Frame 2-year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects who completed their 2 year visit and had available data to collect for this evaluation.
Arm/Group Title Primary 3DKnee Implant
Hide Arm/Group Description:
Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Average Knee Function Score
76.6  (20.0)
3.Primary Outcome
Title Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.
Hide Description Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.
Time Frame 2-year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects who came in for a 2 year visit and completed the x-ray portion of the evaluation.
Arm/Group Title Primary 3DKnee Implant
Hide Arm/Group Description:
Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: participants
0
4.Primary Outcome
Title Safety Assessment
Hide Description Number of device related adverse events and device failures at the 2 year time frame.
Time Frame 2-year
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the study were evaluated for adverse events.
Arm/Group Title Primary 3DKnee Implant
Hide Arm/Group Description:
Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Overall Number of Participants Analyzed 71
Measure Type: Number
Unit of Measure: Events
Revisions of device 2
Number of device related adverse events 18
Total number of operative site events 40
5.Secondary Outcome
Title Oxford Knee Score
Hide Description Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.
Time Frame 2-year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects who completed an Oxford Knee score questionnaire at the 2 year visit.
Arm/Group Title Primary 3DKnee Implant
Hide Arm/Group Description:
Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
36.3  (14.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Primary 3DKnee Implant
Hide Arm/Group Description Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
All-Cause Mortality
Primary 3DKnee Implant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Primary 3DKnee Implant
Affected / at Risk (%) # Events
Total   0/71 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Primary 3DKnee Implant
Affected / at Risk (%) # Events
Total   62/71 (87.32%)    
Blood and lymphatic system disorders   
Anemia   5/71 (7.04%)  5
Edema   2/71 (2.82%)  2
Cardiac disorders   
Heart Complications   5/71 (7.04%)  5
Ear and labyrinth disorders   
Vertigo   2/71 (2.82%)  2
Endocrine disorders   
Diabetes   3/71 (4.23%)  3
Gastrointestinal disorders   
Diarrhea   2/71 (2.82%)  2
Infections and infestations   
Wound infection, rash and/or redness   13/71 (18.31%)  13
Injury, poisoning and procedural complications   
Nausea   2/71 (2.82%)  2
Musculoskeletal and connective tissue disorders   
Arthrofibrosis   8/71 (11.27%)  8
Fracture   4/71 (5.63%)  5
Pain   38/71 (53.52%)  58
Nervous system disorders   
Brain disorder   5/71 (7.04%)  5
Numbness   6/71 (8.45%)  7
Renal and urinary disorders   
Kidney disorder   2/71 (2.82%)  2
Urinary Tract Infection   3/71 (4.23%)  3
Surgical and medical procedures   
Device Instability  [1]  3/71 (4.23%)  3
Vascular disorders   
Swelling   11/71 (15.49%)  12
Indicates events were collected by systematic assessment
[1]
3DKnee device became loose.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manager of Clinical Affairs
Organization: DJO Surgical
Phone: 512-832-9500 ext 6323
EMail: jane.jacob@djosurgical.com
Layout table for additonal information
Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00764673     History of Changes
Other Study ID Numbers: PS - 703
First Submitted: September 30, 2008
First Posted: October 2, 2008
Results First Submitted: November 19, 2010
Results First Posted: March 2, 2011
Last Update Posted: March 2, 2011